Senior Proposal Writing Specialist responsible for developing customer - focused proposals at Highmark Health. Collaborating with stakeholders to create messaging that meets sales objectives and customer needs.
About the role
- Associate Director Scientific/Medical Writing overseeing document preparation at BioNTech. Collaborating with teams to support drug development and regulatory approval processes.
Responsibilities
- Write, edit, and format a wide range of documents (of low to high complexity) required for research, non-clinical, clinical development, and post-approval life cycle management largely according to standard procedures.
- Coordinate the document preparation, review, and approval.
- Check and revise documents with regard to scientific content, completeness, consistency, and standards compliance.
- Manage outsourced tasks: Plan, support SoW set up, coordinate, and manage external writers providing medical writing services.
- Foster knowledge (i.e., by supporting, training, and guiding) and compliance:
- • with relevant processes, templates, and standards.
- • with good writing practices and the structure/formatting requirements for scientific documents.
- • with international pharmaceutical requirements, including applicable guidelines, regulations, and laws.
- Support the implementation of role-relevant tools, guidelines, SOP documents and templates, instructions, and/or training materials.
- Perform with limited supervision complex medical writing tasks for programs and/or low to high complexity documents, where some adaptation of standard procedures is required.
Requirements
- A relevant science/medical university degree, ideally an M.D. or Pharm. D or a Ph.D., ideally with background knowledge in immunology and oncology.
- >5 years (hands-on) experience:
- • working in drug development in a therapeutically relevant field, preferably in oncology and/or immunology.
- • as a scientific and medical writer in the pharmaceutical/biotech industry.
- Prior experience:
- • drafting documents for multiple indications, preferably in BioNTech-relevant indications.
- • drafting alone new or updated CTPs and CSRs required for Phase I-III trials.
- • drafting low to medium complexity variants of the following (new or updated variants): IBs, clinical CTD modules, DSURs/Annual Reports, RMPs, Response documents, Diversity Plans, PIPs/PSPs, and other CTD Module 1 documents.
- • editing/reviewing R&D reports.
- • drafting (from source data) low to medium complexity variants of R&D reports.
- Native-level written and spoken English, good German skills would be advantageous.
- Ability to interpret and summarize scientific results in a clear, unambiguous, and concise manner.
- Excellent attention to detail.
- A ‘can do’ attitude with the ability to work according to tight timelines and to prioritize workload, while concentrating on delivery and adding value.
- Advanced:
- • interpersonal skills, motivation, coordination, and conflict resolution skills.
- • MS Word skills, MS 365 software (TEAMS, SharePoint, PowerPoint & Excel) skills, Adobe Acrobat Pro skills and DMS author user skills.
- Good knowledge of relevant regulations / guidance on the structure, format and content of regulatory documents (e.g., ICH E3, E6, E9, as well as FDA guidance on BB, Diversity Plans, master protocols, EU CTR, GDPR), on relevant technical specifications (e.g., ICH M4).
- the drug development process and the needs of relevant stakeholders, ideally experience in other related roles.
- statistics, trial design, data reporting, and outcome measures used in trials for immunotherapeutic agents (e.g., RECIST).
Benefits
- BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base.
- We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.
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